Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- LTGPaste, Injectable For Vocal Cord Augmentation3Product Code
- LWMDevice, Electrical Dental AnesthesiaUProduct Code
- MCLKit, Test, In Vitro Periodontal3Product Code
- MQCMouthguard, PrescriptionUProduct Code
- MVLCord, RetractionUProduct Code
- QMJPowered Radiofrequency Toothbrush2Product Code
- QNONeuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea2Product Code
- KJJCleanser, Root CanalUProduct Code
- LFDSaliva, ArtificialUProduct Code
- K234015Caphosol® Artifical Saliva (32 doses sachet box)UCleared 510(K)
- K231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayUCleared 510(K)
- K202689Dentilube SprayUCleared 510(K)
- K203567Oral-B Dry Mouth Oral RinseUCleared 510(K)
- K201277Oral-B Dry Mouth Oral RinseUCleared 510(K)
- K181839CVS Health Dry Mouth Spray, OraLabs Dry Mouth SprayUCleared 510(K)
- K190144MucoPEGUCleared 510(K)
- K181194SmartMouth DryMouth Oral RinseUCleared 510(K)
- K180680Salivea Dry Mouth Mouthwash, Salivea Dry Mouth MouthsprayUCleared 510(K)
- K173808Voutia™UCleared 510(K)
- K181134G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral SprayUCleared 510(K)
- K173237Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral MistUCleared 510(K)
- K171542TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth LozengesUCleared 510(K)
- K163029Hydris™ Oral RinseUCleared 510(K)
- K163476LubricityUCleared 510(K)
- K162167Caphosol Artifical Saliva TabletsUCleared 510(K)
- K152201MedActive Oral Gel and SprayUCleared 510(K)
- K152406SalivaMAXUCleared 510(K)
- K142657XEROSTOM SALIVA SUBSTITUTE GELUCleared 510(K)
- K150074Elevate Moisturizing SprayUCleared 510(K)
- K142549Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 ToothpasteUCleared 510(K)
- K122663ORAMOISTUCleared 510(K)
- K123731BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAYUCleared 510(K)
- K120552AIR LIFT/XEROSTOM ARTIFICIAL SALIVAUCleared 510(K)
- K111250DRY MOUTH MOUTHWASHUCleared 510(K)
- K103745BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEFUCleared 510(K)
- K110116XEROS DRY MOUTH PUMPUCleared 510(K)
- K101346GC ORAL MOISTURIZING GELUCleared 510(K)
- K101477BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASHUCleared 510(K)
- K093642NEUTRASALUCleared 510(K)
- K091718NEUTRASALUCleared 510(K)
- K091419VICKS POWERSHOT DRY THROAT & MOUTH RELIEFUCleared 510(K)
- K072306BIOXTRA MOISTURIZING GELUCleared 510(K)
- K071617ORAL NEUTRALIZERUCleared 510(K)
- K062653MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098UCleared 510(K)
- K061331ORAL BALANCE LIQUID/ GELUCleared 510(K)
- K051812TGO SPRAYUCleared 510(K)
- K041563OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCSUCleared 510(K)
- K030802CAPHOSOLUCleared 510(K)
- K024148SALINUM, ORCLAIRUCleared 510(K)
- K981693SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25UCleared 510(K)
- K991938CAPHOSOL ARTIFICIAL SALIVAUCleared 510(K)
- K874106GLANDOSANE (SALIVART) SYNTHETIC SALIVAUCleared 510(K)
- K851026MOI-STIR ORAL SWABSTICK(S)UCleared 510(K)
- K840807THROAT MOI-STIRUCleared 510(K)
- K822971SALIVA SUBSTITUTEUCleared 510(K)
- K810157MOI-STIRUCleared 510(K)
- P790016SALIVARTUPMA Approval
- LMWSolution, Removal, Carries3Product Code
- LPGMaterial, Dressing, Surgical, Polylactic Acid3Product Code
- LQYLocator, Root ApexUProduct Code
- NSJRestoration, Noble MetalNProduct Code
- NSKDentures, PartialNProduct Code
- NSLDentures, FullNProduct Code
- NSMRestoration, ResinNProduct Code
- NSNRestoration, Resin, Crown And BridgeNProduct Code
- NSORestoration, Porcelain-Fused-To-MetalNProduct Code
- NSPRestoration, PorcelainNProduct Code
- NSQRestoration, Base MetalNProduct Code
- NSRProsthesis, OrthodonticNProduct Code
- NXJDenture, Cosmetic OnlyNProduct Code
- OBRMouthguard, Over-The-CounterUProduct Code
- OCOMouthguard, Migraine/Tension HeadacheUProduct Code
- OLROral Wound DressingUProduct Code
- OLSOral Wound Dressing W/Drug And/Or BiologicUProduct Code
- PKJCrown And Bridge Material, Resin BasedNProduct Code
- QUAIntraoral Cooling Device2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
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- UnknownReview Panel
G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K181134
- 510(k) Type
- Traditional
- Applicant
- Sunstar Americas Inc
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/13/2018
- Days to Decision
- 74 days
- Submission Type
- Summary